Patient Safety Incident Response Policy

Read alongside

Complaints Management Policy and Procedure

Duty of Candour Policy

Statutory Notifications Policy

https://clinicalpartners.atlassian.net/wiki/spaces/CMS/pages/1839924123

1.0 Purpose

1.1 This policy supports the requirements of the Patient Safety Incident Response Framework (PSIRF) and sets out Clinical Partners approach to developing and maintaining effective systems and processes for responding to patient safety incidents and issues for the purpose of learning and improving patient safety.

1.2 The PSIRF advocates a co-ordinated and data-driven response to patient safety incidents. It embeds patient safety incident response within a wider system of improvement and prompts a significant cultural shift towards systematic patient safety management.

1.3 This policy supports development and maintenance of an effective patient safety incident response system that integrates the four key aims of the PSIRF:

• compassionate engagement and involvement of those affected by patient safety incidents

• application of a range of system-based approaches to learning from patient safety incidents

• considered and proportionate responses to patient safety incidents and safety issues

• supportive oversight focussed on strengthening response system functioning and improvement.

2.0 Scope

This policy is specific to patient safety incident responses conducted solely for the purpose of learning and improvement across all Clinical Partner's services. Any response that seeks to find liability, accountability or causality is beyond the scope of this policy. This policy does not include:

• complaints, human resources investigations,

• professional standards investigations,

• coronial inquests, criminal investigations,

• claims management,

• financial investigations and audits,

• safeguarding concerns,

• information governance concerns,

• estates and facilities issues

• data incidents

2.1 There are reporting and review and learning processes in place for information governance processes, health and safety reporting, safeguarding.

2.2 Responses under this policy will follow a systems-based approach. This recognises that patient safety is an emergent property of the healthcare system: that is, safety is provided by interactions between components and not from a single component. Responses will not take a ‘person-focussed’ approach where the actions or inactions of people, or ‘human error,’ are stated as the cause of an incident.

2.3 There is no remit to apportion blame or determine liability, preventability or cause of death in a response conducted for the purpose of learning and improvement. Other processes, such as claims handling, human resources investigations into employment concerns, professional standards investigations, coronial inquests and criminal investigations, exist for that purpose. The principle aims of each of these responses differ from those of a patient safety response and are outside the scope of this policy.

2.4 Information from a patient safety response process can be shared with those leading other types of responses, but other processes should not influence the remit of a patient safety incident response.

3.0 Our Patient Safety Culture

3.1 Clinical Partners provides a culture that is just and open. We support open and transparent reporting to drive improvement and safety.

4.0 Roles

4.1 The Board

The Board of Clinical Partners is responsible and accountable for effective patient safety incident management. This includes supporting and participating in cross system/multi-agency responses and/or independent patient safety incident investigations (PSIIs) where required.

4.2 PSIRF Executive Lead

The Board has identified the Chief Medical Officer (CMO) as its PSIRF executive lead to support the responsibilities outlined below. The MD will also provide direct leadership, advice, and support in complex/high profile cases, and liaise with external bodies as required.

The MD has overarching responsibility for quality and more specifically, patient safety within Clinical Partners.

4.3 PSIRF executive lead responsibilities

• The PSIRF will ensure Clinical Partners meets national patient safety incident response standards.

• The PSIRF executive lead, supported by the rest of the board/leadership team, will oversee the development, review and approval of the organisation’s policy and plan for patient safety incident response, ensuring they meet the expectations set out in the patient safety incident response standards where relevant.

• Ensure PSIRF is central to overarching safety governance arrangements

• The Board will have access to relevant information about their organisation’s preparation for and response to patient safety incidents, including the impact of changes following incidents.

• It is also the PSIRF executive lead’s responsibility to ensure:

• patient safety incident reporting and response data, learning response findings, safety actions, safety improvement plans, and progress are discussed at board meetings.

• roles, training, processes, accountabilities, and responsibilities of staff are in place to support an effective organisational response to incidents.

• mechanisms for the ongoing monitoring and review of the patient safety incident response plan to include:

• delivery of safety actions and improvement must form part of the overarching quality governance arrangements and be supported by clear financial planning to ensure appropriate resources are allocated to PSIRF activities and safety improvement.

• the board monitor the balance of resources going into patient safety incident response versus improvement. Repeat responses should be avoided when sufficient learning is available to enable the development and implementation of a safety improvement plan.

Updates to the policy and plan are made as required as part of regular oversight processes. An overall review of the patient safety incident response policy and plan will be undertaken at least every four years alongside a review of all safety actions.

Quality assure learning response outputs

A final report will be produced for all individual PSIIs (Appendix 3 PSII template) and reviewed and signed off as complete. Sign-off of PSIIs is the responsibility of the Board.

The MD is responsible for reviewing PSII reports in line with the patient safety incident response standards and sign off as finalised. They may be supported in this by relevant colleagues as appropriate.

While a full report for submission to the Board may not be produced for learning response methods other than PSII, the MD will monitor the quality of all response methods. A sampling approach may be best for this.

Clinical Partners will review all safety actions implemented in response to learning or wider safety improvement plans at the quarterly Clinical Governance meeting, to check delivery of required improvement. Progress on individual actions will be reviewed at least monthly using relevant data, and an overall assessment of the delivery of all safety actions at least every four years as part of the requirements to review patient safety incident response plans.

4.3 Integrated care board (ICB) and ICB lead

NHS ICBs have a responsibility to establish and maintain structures to support a co-ordinated approach to oversight of patient safety incident response in all the services within their system. Clinical Partners does not have an ICB as an Independent provider of Mental Health Outpatient services but will engage in any requests from ICBs.

4.4 Patient safety partners

Duty of Candour to patients and family and responding to immediate risk

Clinical Partners on identifying an incident will be open with those affected, explaining what has happened, listening to any questions and/or concerns, and explaining what will happen next. Any immediate risks to the patient(s) or others and actions that may be required to mitigate those risk will be considered.

The requirement to comply with Duty of Candour regulations is unchanged: Clinical Partners will inform the patient/family/carers of any notifiable patient safety incident and follow all the requirements of its Duty of Candour Policy. In cases of mental health related homicide, this will be both the patient and their family, and the victim’s family.

While legal obligations associated with Duty of Candour apply to those in receipt of care, the moral obligation to be open, honest, supportive, and inclusive must be upheld for all affected. Further information is included within Engaging and involving patients, families and staff following a patient safety incident 

4.5 Care Quality Commission

The Care Quality Commission’s (CQC’s) assessment of a provider’s leadership and safety considers an organisation’s ability to respond effectively to patient safety incidents, including whether change and improvement follow its response to patient safety incidents. CQC teams will apply the PSIRF and associated patient safety incident response standards as part of its assessment of the strength of an organisation’s systems and processes for preparing for and responding to patient safety incidents.

Clinical Partners will inform CQC of incidents as required by the Health and Social Care Act (2008) and set out in CQC’s guidance on statutory notifications in accordance with Clinical Partners Notification Policy.

4.6 General Practitioners

GPs provide an important link between the patient and CP. They are integral to patient safety and Clinical Partners will inform them of any serious patient safety issues and engage with them to identify actions to mitigate risks.

4.7 Clinicians

Clinical Partners works with independent clinical specialists to provide its services to patients. All clinicians are subject to rigorous checks to protect patients. In the event of a patient safety incident clinicians will be engaged in any investigation relevant to their practice and any lessons learned cascaded to all clinicians.

4.8 Commissioners of Clinical Partners services.

Clinical Partners will work with those who commission its services as patient safety partners to effectively respond to PSIIs to deliver a co-ordinated approach to incidents. This commitment to collaborative working is based on openness and the principles of the PSIRF.

This may include collaboration with local PSII Leads, ICB Leads or Regional Independent Investigation Teams (RIIT). Independent PSII reports must be shared with internal and external stakeholders, including the affected individuals and families, and should be written in a clear and accessible way as described in the Patient safety incident response standards. Where possible independent PSIIs may be published in full. This however must consider if publication could prevent a similar patient safety incident, the wider public interest could outweigh the rights of individuals to privacy.

Rights must be balanced against the wider public interest when deciding whether to publish. Article 8 of the European Convention on Human Rights (ECHR), must be considered, the right for both individual and family life.

A contemporaneous written record of the factors considered in the decision to publish sensitive material or not must be retained.

5.0 Addressing Health Inequalities

5.1 Clinical Partners will address any patient safety concerns and responses to support health equality and reduce inequality. We will:

• keep our services under review to help identify any disproportionate risk to patients with specific characteristics and use this information to inform our patient safety incident response.

• be sensitive in our engagement with patients, families and staff following a patient safety incident with consideration of their different needs.

• uphold a system-based approach (not a ‘person focussed’ approach) and ensure staff have the relevant training of a just culture.

6.0 Engaging and Involving Patients, Families and Staff Following a Patient Safety Incident

6.1 The PSIRF recognises that learning and improvement following a patient safety incident can only be achieved if supportive systems and processes are in place. It supports the development of an effective patient safety incident response system that prioritises compassionate engagement and involvement of those affected by patient safety incidents (including patients, families and staff). This involves working with those affected by patient safety incidents to understand and answer any questions they have in relation to the incident and signpost them to support as required.

6.2 Those affected by a patient safety incident may have a range of needs (including clinical needs) as a result and these must be met where possible. This is part of Clinical Partners duty of care. Meeting people’s needs not only helps alleviate the harm experienced, but also helps avoid compounding that harm. While we cannot change the fact that an incident has happened, it is always within our gift to compassionately engage with those affected, listen to, and answer their questions and try to meet their needs.

6.3 Engaging with those affected by a patient safety incident improves our understanding of what happened, and potentially how to prevent a similar incident in future. Patients, their family members, and carers may be the only people with insight into what occurred at every stage of a person’s journey through the healthcare system. Not including those insights could mean an incomplete picture of what happened is created. Similarly, staff have important contributions to make about their experience of the incident and the working environment at the time and should be supported to share their account.

7.0 Engagement Principles

7.1 Nine principles inform the design of Clinical Partners systems and processes for engaging and involving those affected by patient safety incidents. Due to the range of incidents that can occur, and the different needs of individuals affected, the principles must be flexibly applied when engaging with or involving those affected by patient safety incidents in an investigation.

1. Apologies are meaningful. Apologies need to demonstrate understanding of the potential impact of the incident on those involved, and a commitment to address their questions and concerns. Ideally, an apology communicates a sense of accountability for the harm experienced, but not responsibility for it ahead of investigation. Getting an apology right is important – it sets the tone for everything that follows. Apologising is also a crucial part of the Duty of Candour.

2. Approach is individualised. Engagement and involvement should be flexible and adapt to individual and changing needs. These needs could be practical, physical, or emotional. Engagement leads should recognise that every response might need to be different, based on an understanding of the different needs and circumstances of those affected by an incident.

3. Timing is sensitive. Some people can feel they are being engaged and involved too slowly or too quickly, or at insensitive times. Engagement leads need to talk to those affected about the timing and structure of engagement and involvement, and any key dates to avoid (e.g. birthdays, funeral dates, anniversaries), particularly where someone has lost a loved one.

4. Those affected are treated with respect and compassion. Everyone involved in a learning response should be treated respectfully. There should be a duty of care to everyone involved in the patient safety incident and subsequent response, and opportunities provided for open communication and support through the process. Overlooking the relational elements of a learning response can lead to a breakdown of trust between those involved (including patients, families, and healthcare staff) and the organisation.

5. Guidance and clarity are provided Patients, families, and healthcare staff can find the processes that follow a patient safety incident confusing. Those outside the health service, and even some within it, may not know what a patient safety incident is, why the incident they were involved in is being investigated or what the learning response entails. Patients, families, and healthcare staff can feel powerless and ill-equipped for the processes following a patient safety incident. Therefore, all communications and materials need to clearly describe the process and its purpose, and not assume any prior understanding.

6. Those affected are ‘heard’. Everyone affected by a patient safety incident should have the opportunity to be listened to and share their experience. They will all have their individual perspective on what happened and each one is valid in building a comprehensive picture to support learning. Importantly, the opportunity to be listened to is also part of restoring trust and repairing relationships between organisations and staff, patients, and families.

7. Approach is collaborative and open. An investigation process that is collaborative and open with information, and provides answers, can reduce the chance litigation will be used as a route for being heard. The decision to litigate is a difficult one. Organisations must not assume that litigation is always about establishing blame – some feel it is the only way to get answers to their questions.

8. Subjectivity is accepted Everyone will experience the same incident in different ways. No one truth should be prioritised over others. Engagement leads should ensure that patients, families, and healthcare staff are all viewed as credible sources of information in response to a patient safety incident.

9. Strive for equity Organisations may differ from patients, families, and healthcare staff in what they consider is the appropriate response to a patient safety incident. The opportunity for learning should be weighed against the needs of those affected by the incident. Engagement leads need to understand and seek information on the impact of how they choose response types on those affected by incidents and be aware of the risk of introducing inequity into the process of safety responses.

8.0 Patient Safety Incident Response Planning

8.1 PSIRF supports organisations to respond to incidents and safety issues in a way that maximises learning and improvement, rather than basing responses on arbitrary and subjective definitions of harm. Beyond nationally set requirements, organisations can explore patient safety incidents relevant to their context and the populations they serve rather than only those that meet a certain defined threshold. Appendix 2 Clinical Partners Patient safety incident response plan.

9.0 Resources and Training to Support Patient Safety Incident Response

9.1 Specific knowledge and experience are required for those leading learning responses and those in oversight roles. This includes knowledge of systems thinking and system-based approaches to learning from patient safety incidents.

9.2 Those involved in the quality assurance of patient safety incident response (i.e. provider boards/executive leads) must have the knowledge to constructively challenge the strength and feasibility of safety actions to improve underlying system issues. They must be able to recognise when the proposed safety actions following a patient safety incident response does not take a system-based approach; for example, where they inappropriately focussed on revising policies without understanding ‘work as done,’ or involve self-reflection for certain individuals rather than reviewing wider system influences.

9.3 Our plan is to deliver training to the required standard over the next 12 months.

10.0 Training Provider Requirements

10.1 Training will either be conducted by those who have:

• attended courses in learning from safety incidents amounting to more than 30 days,

• are up to date in learning response best practice and have both conducted and reviewed learning responses.

are accreditation with a recognised organisation.

10.2 Training requirements are outlined in Appendix 1.

11.0 Our Patient Safety Incident Response Plan

11.1 Our plan sets out how Clinical Partners intends to respond to patient safety incidents over a period of 12 to 18 months. (Appendix 2). The plan is not a permanent set of rules that cannot be changed. We will remain flexible and consider the specific circumstances in which each patient safety incident occurred and the needs of those affected, as well as the plan.

12.0 Reviewing our Patient Safety Incident Response Policy and Plan

12.1 Our patient safety incident response plan is a ‘living document’ that will be appropriately amended and updated as we use it to respond to patient safety incidents. We will review the plan every 12 to 18 months to ensure our focus remains up to date; with ongoing improvement and transformation work our patient safety incident profile is likely to change. This will also provide an opportunity to re-engage with stakeholders to discuss and agree any changes made in the previous 12 to 18 months.

12.2 Updated plans will be published on our website, replacing the previous version.

12.3 A rigorous planning exercise will be undertaken every four years and more frequently if appropriate to ensure efforts continue to be balanced between learning and improvement. This more in-depth review will include reviewing our response capacity, mapping our services, a wide review of organisational data (for example, patient safety incident investigation (PSII) reports, improvement plans, complaints, claims, staff survey results, inequalities data, and reporting data) and wider stakeholder engagement.

13.0 Responding to Patient Safety Incidents

13.1 The focus of a system-based approach is examining the components of a system (e.g. person(s), tasks, tools and technology, the environment, the wider organisation) and understanding their interdependencies (i.e. how they influence each other) and how those interdependencies may contribute to patient safety.

13.2 A system-based approach recognises that patient safety is an emergent property of the healthcare system: that is, safety arises from interactions and not from a single component, such as actions of people.

13.3 A system-based approach therefore recognises that it is insufficient to look only at one component, such as only the people involved. A system-based approach will identify where changes need to be made and then monitored within the system to improve patient safety.

13.4 Evidence suggests that, despite best intentions, RCA prompts simple linear cause and-effect analysis and has consistently failed to deliver benefits of the scale and quality needed.

13.5 The methods promoted by PSIRF for learning from patient safety incidents differ from RCA in the following core ways:

• They recognise that outcomes in complex systems result from the interaction of multiple factors – learning should not focus on uncovering a (root) cause, but instead should explore multiple contributory factors.

• They do not distinguish between care and service delivery problems. Instead, they explore contributory factors, including ‘individual acts’ in the context of the whole system.

• They use tools to explore multiple interacting contributory factors rather than forcing a single analytical pathway. A framework based on the well-established SEIPS (Systems Engineering Initiative for Patient Safety) replaces the contributory factors classification framework. This is made up of six factors or elements that when considered together cover all elements of a ‘system.’

13.6 SEIPS is the systems-based framework endorsed by PSIRF. It is a framework for understanding outcomes within complex systems which can be applied to support the analysis of incidents and safety issues more broadly. Clinical Partners, with relatively few serious patient incidents, has its own framework for reporting and analysing incidents based on persons, task, tools and technology, the environment, wider organisation, and their interdependencies, but will keep this under review.

14.0 Patient Safety Incident Reporting Arrangements

14.1 All office-based staff using SalesForce have access to the online reporting system in SalesForce.

14.2 Clinicians and employees not using SalesForce will have access to the ‘Incident Reporting Form’ on SharePoint.

14.3 Clinicians will receive information on incident reporting during their induction. (Data security breaches, complaints and Safeguarding Concerns should be managed in accordance with the appropriate policies and reporting forms.)

14.4 Following an incident, the person involved or receiving information that constitutes an incident should complete the SalesForce Report and Issue Notification process and contact their line Manager, to discuss the incident. The governance team and Registered Manager will be contacted automatically. The incident will be reviewed by the Governance Manager to see what further action needs to be taken. Generally minor incidents may not require further investigation if there has been local resolution unless there are similar trends identified.

14.5 If the incident is major or catastrophic events in health care where the potential for learning is so great, or the consequences to patients, families and carers, staff or organisations are so significant, they may warrant using additional resources to mount a comprehensive response. Serious incidents can extend beyond incidents which affect patients directly and include incidents which may indirectly impact patient safety or an organisation’s ability to deliver on-going healthcare. 

14.6 Serious incidents are often triggered by events leading to serious outcomes for patients, staff and/or the organisation involved. They may be identified through various routes including, but not limited to, the following:

• Incidents identified during the provision of healthcare by a provider e.g. patient safety incidents or serious/distressing/catastrophic outcomes for those involved

• Allegations made against or concerns expressed about a clinician by a patient or third party

• Initiation of other investigations for example: Serious Case Reviews (SCRs)

• Safeguarding Adult Reviews (SARs)

• Controlled drug incidents

14.7 The Governance Manager will inform the PSIR Lead for Clinical Partners who will initiate a PSII.

14.8 The Board of Clinical Partners has a duty to encourage an open culture between organisations, healthcare teams, staff, patients and/or carers. As required Clinical Partners will co-operate and collaborate with partner agencies to minimise duplication, uncertainty and/or confusion relating to the serious incident investigation process.

14.9 Those affected by the incident should be signposted to independent advocacy services when required and be given a single point of contact for any further questions or requests and to keep them updated with the progress of the investigation.

14.10 Incidents will be reviewed at Clinical Governance meetings and signed off at Board meetings. Lessons learned will be cascaded to staff via team meetings or as part of the Communication Plan. Any lessons learned, training or changes to procedure will be implemented at the earliest opportunity. It is important that staff members receive adequate support from managers and other members of the team.  Where extra training is needed, this will be put in place. 

14.11 Patients or their relatives will be informed of the incident, any investigation and actions taken to prevent a reoccurrence in accordance with our Duty of Candour Policy and Notifications Policy.

15.0 Patient Safety Incident Response Decision Making

15.1 In the case of a PSIR, Clinical Partners’ PSIR Lead or Governance Manager will appoint a lead investigator to communicate with the individuals involved to arrange a meeting. They will then agree the terms of reference of the investigation and how the report and findings will be shared at its conclusion.

16.0 Safety Action Development and Monitoring Improvement

16.1 Our processes for improvement are included in our Quality Improvement Strategy and Clinical Quality Strategy. The recommendations from our Patient Safety Investigations and Patient Safety Reviews will flow through these processes linking them in directly to our Quality Improvement work.

16.2 At the conclusion of a Patient Safety Incident Investigation (PSII) the final report will be submitted to the Clinical Governance Group for discussion and agreement of the system improvement plan. The improvement plan will be agreed and logged on the Clinical Governance action log. Lessons learned will cascaded across the organisation through various mediums including Clinical Partner’s Communication Plan, quality and safety matters alerts.

17.0 Safety Improvement Plans

17.1 We have created a safety improvement plan to tackle broad areas for improvement to address our overarching system issues that are part of our ongoing Transformation Project due for completion April 2024.

18.0 Oversight Roles and Responsibilities

19.0 Complaints and Appeals

All complaints about the way Clinical Partners has responded to a patient safety incident will be responded to sensitively in accordance with our complaint's procedure. This is a three-stage process with independent adjudication at stage three by ISCAS.

How to complain is published on our website.

Appendix 1: Training Plan

Appendix 2: Clinical Partners Safety Incident Response Plan

Introduction

This patient safety incident response plan sets out how Clinical Partners intends to respond to patient safety incidents over a period of 12 to 18 months. The plan is not a permanent rule that cannot be changed. We will remain flexible and consider the specific circumstances in which patient safety issues and incidents occurred and the needs of those affected.

Our services

Clinical Partners are one of the UK’s leading providers of mental health services who work both privately and with the NHS to help people and families experiencing mental and emotional difficulties to get the support they need.

Through face-to-face and online appointments, our services include specialist diagnostic assessments, general outpatient psychiatry, psychology, and psychotherapy for people of all ages.

Our priority is helping patients and meaningful others feel better. This means only using treatments and therapies that have been proven to work. Our clinicians all use an evidence-based approach that follows guidelines from the National Institute for Health and Care Excellence (NICE).

Defining our patient safety incident profile

Clinical Partners has an Exclusion Policy and Triage Risk Assessment process to ensure that we only treat patients who we believe we can treat safely. Despite these safeguards there are some patients who, due to circumstances or escalation of their mental health issues may affect their risk profile.

We have defined our patient safety issues by reviewing the data we hold about incidents reported and investigated over the last three years.

Our patient safety improvement profile has been developed following:

• Analysis of patient incidents –

  • Where an incident type is well understood because previous incidents of this type have been thoroughly investigated and national or local improvement plans, targeted at the contributory factors are being implemented and monitored for effectiveness. CP recognises that resources may be better directed at improvement rather than repeat investigation (or other type of learning response).

  • Risks or broad patient safety issues may also be identified during patient safety incident response planning that could benefit from focussed improvement efforts rather than further incident responses.

  • CP may consider conducting a thematic review of past learning responses to inform the development of our safety improvement plan.

• Complaints:

  • Complaint themes were reviewed and a thematic analysis undertaken which was triangulated with other data sources such as Trust Pilot.

• Analysis of audit

  • Planned audit programme and responsive audits around relevant national, regional, and locally driven improvement and service transformation programmes are undertaken by CP. These may identify patient safety issues.

• Patient and stakeholder feedback.

  • A valuable source of information that may directly identify patient safety concerns or themes that indicate possible system errors.

• System reviews

  • due to increased activity and pressure on operating platforms. Currently CP is going through an organisational and IT transformation project to improve services for patients and staff. Improved data availability and visibility to reduce risk.

Risk profile

Death by suicide - Above all else, suicide is tragic and unpredictable with respect to the onset state of mind immediately preceding the act. We recognise also however, that in a wider sense there are measures and interventions that can, cumulatively act to make suicide more preventable.

Overdose – any overdose event is again unpredictable. As a service we exclude anyone who has recently overdosed as we are not able to provide the level of care to support individuals in crisis.

Prescribing – although prescribing errors are rare in Clinical Partners they have occurred, and processes are in place to report and review incidents.

Feedback – including but not exclusively

• complaints

• Safeguarding cases

• staff suspensions

• data from quality surveillance processes

Maintaining a contemporaneous record of patient care – that identify patient risk, is readily available to clinicians and those that need access to provide the safest possible service.

Never Events - Never Events are defined as Serious Incidents that are wholly preventable because guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and should have been implemented by all healthcare providers.

As we develop our plan, we will engage with stakeholders to review and further define patient safety risks.

Our patient safety incident response plan: national requirements

Our patient safety incident response plan: local focus

Safety improvement plans

CP has adopted several methods to improve patient safety and deliver improvement plans:

• CG has created an organisation-wide safety improvement plan summarising improvement work that is broken down by source type

  • From reported incidents

  • Audit reviews

  • Engagement with stakeholders

These in turn have created individual safety improvement plans, each focussing on a specific service, pathway, or location. These may be following output from learning responses undertaken in relation to single incidents or collectively, when it is felt that there is sufficient understanding of the underlying, interlinked system issues.

Appendix 3: Patient Safety Incident Investigation (PSII) Report TEMPLATE

Patient safety incident investigation (PSII) report

_{On completion of your final report, please ensure you have deleted all the information boxes and text.}

Notes on the PSII template

This national template is designed to improve the recording and standardisation of PSII reports and facilitate national collection of findings for learning purposes. This format will continue to be evaluated and developed by the National Patient Safety Team.

A PSII report must be accessible to a wide audience and make sense when read on its own. The report should:

• Use clear and simple everyday English whenever possible.

• Explain or avoid technical language.

• Use lists where appropriate.

• Keep sentences short. 

List who will receive the final draft and the final report (e.g. patients/relatives/staff involved¸ board). Remove names prior to distribution.

About patient safety incident investigations

Patient safety incident investigations (PSIIs) are undertaken to identify new opportunities for learning and improvement. PSIIs focus on improving healthcare systems; they do not look to blame individuals. Other organisations and investigation types consider issues such as criminality, culpability or cause of death. Including blame or trying to determine whether an incident was preventable within an investigation designed for learning can lead to a culture of fear, resulting in missed opportunities for improvement. 

The key aim of a PSII is to provide a clear explanation of how an organisation’s systems and processes contributed to a patient safety incident. Recognising that mistakes are human, PSIIs examine ‘system factors’ such as the tools, technologies, environments, tasks and work processes involved. Findings from a PSII are then used to identify actions that will lead to improvements in the safety of the care patients receive.

PSIIs begin as soon as possible after the incident and are normally completed within three months. This timeframe may be extended with the agreement of those affected, including patients, families, carers and staff.

If a PSII finds significant risks that require immediate action to improve patient safety, this action will be taken as soon as possible. Some safety actions for system improvement may not follow until later, according to a safety improvement plan that is based on the findings from several investigations or other learning responses.

The investigation team follow the Duty of Candour and the Engaging and involving patients, families and staff after a patient safety guidance in their collaboration with those affected, to help them identify what happened and how this resulted in a patient safety incident. Investigators encourage human resources teams to follow the Just Culture guide in the minority of cases when staff may be referred to them.

PSIIs are led by a senior lead investigator who is trained to conduct investigations for learning. The investigators follow the guidance set out in the Patient Safety Incident Response Framework and in the national patient safety incident response standards.

A note of acknowledgement

Executive summary

Incident overview

Summary of key findings

Summary of areas for improvement and safety actions

Contents

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Background and context

Description of the patient safety incident

Investigation Approach

Investigation team

Summary of investigation process

Terms of reference

Information gathering

Findings

Summary of findings, areas for improvement and safety actions

 Safety action summary table

Appendices

References